MAUDE Adverse Event Report: MICROVENTION, INC. HP8 AZUR HYDROPACK 18; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION

Model Number	45-880035
Medical Device Problem Codes	Device Difficult to Setup or Prepare (1487); Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/28/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A search for non-conformances associated with this part/lot number combination did not reveal any production-related issues relevant to the complaint that occurred during manufacturing of the device.The device was stated to be available for return to the manufacturer for evaluation but has not yet been returned despite a device return attempt.Ongoing attempts will be made for the device return.The alleged product issue/event as described could not be confirmed.If the device is received at a later date, an investigation will be performed and a supplemental mdr will be submitted.
Event or Problem Description
As reported: this was a splenic artery embolization.The physician was taking down the main portion of splenic artery which measured ~5mm diameter.He had in adequate support and was accessing the right femoral.A 2.4f microcatheter was used to deliver the coils.He deployed a 6x20, 018cx coils which landed perfectly with no issues.Then he went in to deploy the hydropack.The physician and his tech were being coached.The coil was flushed prior to removal from the hoop, the introducer sheath was inserted into the microcatheter hub, and no issues occurred during initial advancement.Under fluoro, the physician advanced the hydropack to the backstop and ensured there was adequate room for the coil to come out of the microcatheter to start initial form.He advanced the microcatheter to pack in the hydropack and then retracted to make space for additional advancement.On the second go around of advancing the hydropack into the pack, he said he could feel that the coil detached.The physician stopped, checked fluoro to confirm location and gently tested the pusher wire to confirm.The coil had detached within the microcatheter.The initial pack that had formed was not tangled in the backstop cx coil, and the physician was able to remove the entire system (microcatheter + hydropack) from the patient and remove the coil from the catheter.After flushing and confirming the microcatheter integrity, he re-inserted the microcatheter and got it into position.He then utilized another hydropack without issue and capped the coil mass with another 6x20, 018cx coils.All other aspects of the procedure went as planned and the desired result was achieved.It was mentioned that the hydropack coil felt like it had more friction removing from the flushed hoop than the 018cx coils that were used.This was the first time these coils were used.There was an issue with the first hydropack, as it detached on its own.The second hydropack that was used deployed correctly.All other coils deployed correctly.Estimated blood loss: <250cc no patient injury reported.
Additional Manufacturer Narrative
Items returned for evaluation: pusher; implant.Items not returned for evaluation: introducer; shrink lock; dispenser hoop; microcatheter.The visual analysis of the returned device found that the implant was not attached to the pusher.No damage was found on the pusher.The implant was returned damaged and separated from the pusher.The investigation found that the pusher's monofilament was broken, which indicates that the device experienced a tensile break.The investigation of the returned coil system found the implant damaged and separated from the pusher; however, no indications of activation using a detachment controller was found on the pusher heater coil.The investigation found the pusher's monofilament with a tensile break shape at the tip, which is consistent with the device experiencing force that exceeded the strength of the monofilament causing the implant to separate from the pusher.The physical evaluation of the device could not identify the conditions or circumstances that led to the implant damage, but the damage is consistent with the device experiencing forces over specification.The microcatheter used in the procedure was not returned, so the investigation could not determine if it had caused or contributed to the reported complaint.
Event or Problem Description
As reported: this was a splenic artery embolization.The physician was taking down the main portion of splenic artery which measured ~5mm diameter.He had in adequate support and was accessing the right femoral.A 2.4f microcatheter was used to deliver the coils.He deployed a 6x20, 018cx coils which landed perfectly with no issues.Then he went in to deploy the hydropack.The physician and his tech were being coached.The coil was flushed prior to removal from the hoop, the introducer sheath was inserted into the microcatheter hub, and no issues occurred during initial advancement.Under fluoro, the physician advanced the hydropack to the backstop and ensured there was adequate room for the coil to come out of the microcatheter to start initial form.He advanced the microcatheter to pack in the hydropack and then retracted to make space for additional advancement.On the second go around of advancing the hydropack into the pack, he said he could feel that the coil detached.The physician stopped, checked fluoro to confirm location and gently tested the pusher wire to confirm.The coil had detached within the microcatheter.The initial pack that had formed was not tangled in the backstop cx coil, and the physician was able to remove the entire system (microcatheter + hydropack) from the patient and remove the coil from the catheter.After flushing and confirming the microcatheter integrity, he re-inserted the microcatheter and got it into position.He then utilized another hydropack without issue and capped the coil mass with another 6x20, 018cx coils.All other aspects of the procedure went as planned and the desired result was achieved.It was mentioned that the hydropack coil felt like it had more friction removing from the flushed hoop than the 018cx coils that were used.This was the first time these coils were used.There was an issue with the first hydropack, as it detached on its own.The second hydropack that was used deployed correctly.All other coils deployed correctly.Estimated blood loss: <250cc.No patient injury reported.

• Brand Name: HP8 AZUR HYDROPACK 18
• Common Device Name: DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo CA 92656
• Manufacturer Contact: terrence callahan ; 35 enterprise; aliso viejo, CA 92656 ; 7142478000
• MDR Report Key: 20424735
• Report Number: 2032493-2024-00750
• Device Sequence Number: 8735665
• Product Code: KRD
• UDI-Device Identifier: 00842429118061
• UDI-Public: (01)00842429118061(11)230706(17)280630(10)0000389680
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K223050
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 45-880035
• Device Lot Number: 0000389680
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/28/2024
• Supplement Date Received by Manufacturer: 11/01/2024
• Initial Report FDA Received Date: 10/10/2024
• Supplement Report FDA Received Date: 11/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/06/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 2.4F PROGREAT.
• Patient Age: 39 YR
• Patient Sex: Male
• Patient Weight: 55 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American